MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2011-04-26 for SMARTPLUG 500 MODEL 500 manufactured by Medennium, Inc..
[2164724]
(b)(4), md et all. , "prevalence of canaliculitis requiring surgical removal of smart plugs", ophthalmic plastic reconstructive surgery, vol 25, no6, 2009 was written regarding smart plug and the prevalence of canaliculitis in one practice as (b)(4). The average onset of symptoms was at 3 years and in 3 cases in as little as 3, 4 and 5 months, respectively. The plugs were inserted from 2002 to 2007. Seventeen patients had smart plug inserted ages (b)(6), 15 female and 2 male. Two were irrigated and 7 received topical antibiotics. One received topical and oral antibiotics. One received oral antibiotics only. No medical treatment was attempted in 6 of the patients. Canaliculotomy was performed on all patients. One patient required bilateral jones tubes due to chronic epiphora. One patient required silicone intubation for epiphora. The reported outcomes were that 9 resolved, 4 had dry eye, 2 having epiphora one requiring silicone intubation and one requiring jones tubes. Two had no outcomes listed one with no medical treatment attempted and one with topical antibiotics attempted. It appears that all patients with listed outcomes had resolution of the canaliculitis.
Patient Sequence No: 1, Text Type: D, B5
[9257454]
From the dates identified on the article we only show shipping records from 2002 to 2005 of a total of (b)(4). Important to note that no medical treatment was attempted on 6 of the 17 patients so the statement should read all affected patients were treated by canaliculotomy as the treatment of choice. The long term studies suggest 3. 9% for silicone headed plugs. Chen sx, lee ga 2007 reference no. 10 in the hill article. So is there a substantial difference in the risks of canaliculitis with either headed silicone plugs or intracanalicular smartplugs? 3. 9% silicone vs. 1. 86% smartplug? Reference number 7. The smartplug study group headed by joseph mauriello m. D. In this article among 28 patients with diagnosed complications 9 of them were successfully treated without the need for surgery. This is about 33%. Is the bersani/hill approach to resolving complications the right approach? Is it to perform surgery without attempting to resolve the situation by the use of antibiotics oral/topical waiting for resolution of infection and then attempting irrigation? Also important to note that before giving up on antibiotic treatment it may be helpful to study if the antibiotic being used is the correct one for the type of bacteria being treated. The patients here presented have resolved their canaliculitis and no further reports can be expected. This report is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031959-2011-00001 |
| MDR Report Key | 2222483 |
| Report Source | 03 |
| Date Received | 2011-04-26 |
| Date of Report | 2011-04-25 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2011-04-18 |
| Device Manufacturer Date | 2002-01-01 |
| Date Added to Maude | 2012-06-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIAN ABADIA |
| Manufacturer Street | 9 PARKER, SUITE 150 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497899000 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPLUG |
| Generic Name | PUNCTUM PLUG |
| Product Code | LZU |
| Date Received | 2011-04-26 |
| Model Number | 500 |
| Catalog Number | MODEL 500 |
| Lot Number | SEVERAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDENNIUM, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-04-26 |